MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | MAX |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Recent Cleared Devices (20 of 900)
Showing 20 most recent of 900 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Jul 17, 2026 | SESE |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | Jul 14, 2026 | SESE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | Jul 1, 2026 | SESE |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | Jun 15, 2026 | SESE |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | May 29, 2026 | SESE |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | May 28, 2026 | SESE |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | May 15, 2026 | SESE |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | May 12, 2026 | SESE |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | Carlsmed, Inc. | May 9, 2026 | SESE |
| K261067 | BEE PLIF Cage | NGMedical GmbH | Apr 30, 2026 | SESE |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | Feb 26, 2026 | SESE |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | Feb 23, 2026 | SESE |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | Feb 4, 2026 | SESE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | Jan 23, 2026 | SESE |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | Jan 8, 2026 | SESE |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | Dec 19, 2025 | SESE |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | Nov 25, 2025 | SESE |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | Oct 28, 2025 | SESE |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Oct 24, 2025 | SESE |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | Sep 18, 2025 | SESE |
Top Applicants
- Medtronic Sofamor Danek USA, Inc. — 34 clearances
- Nu Vasive, Incorporated — 34 clearances
- Life Spine, Inc. — 26 clearances
- Spineology, Inc. — 22 clearances
- Globus Medical, Inc. — 20 clearances
